Tag
FDA
15 articles
Trump's FDA Pick Faces Vape Crisis as China Floods U.S. Market
Dr. Heidi Overton's confirmation hearing comes as over 80 percent of vapes sold in America are illegal, with Chinese manufacturers raking in $11 billion annually.
AbbVie's Juvmo Approval Validates $8.7B Cerevel Bet, Eyes $1.4B Peak Sales
FDA approval of Juvmo, AbbVie's once-daily Parkinson's treatment, delivers near-term validation of its Cerevel acquisition and positions a new growth driver as Humira patent cliff deepens.
Novo Nordisk's Denecimig Delayed to 2027; FDA Manufacturing Review Extends Timeline
Novo Nordisk said the FDA extended its review of denecimig for hemophilia A due to manufacturing site remediation, pushing the expected U.S. launch into 2027.
Novo Nordisk Delays Denecimig US Launch to H1 2027 on Manufacturing Issues
FDA manufacturing facility concerns push haemophilia A treatment past original 2026 target; clinical data deemed acceptable
Anti-Abortion Groups Sue to Block Abortion Pill, Citing Environmental Law
Students for Life of America filed notice to sue the FDA over mifepristone, claiming the agency violated the Endangered Species Act by failing to test environmental impacts.
American Regent Recalls Epinephrine Injections Over Contamination Risk
The pharmaceutical company pulled three lots of epinephrine injections after discovering particulate matter including glass and nylon that could cause blood clots or organ damage.
11,458 Sickened in Largest U.S. Cyclospora Outbreak Linked to Mexican Lettuce
Federal health officials traced the parasitic infection across 20 states to iceberg lettuce from Taylor Farms de Mexico, with illnesses continuing to climb since the July recall.
Revolution Medicines' Rasonque Wins FDA Nod in Pancreatic Cancer
Daraxonrasib cleared 6.5 months early with Phase 3 data showing median 13.2-month survival versus 6.7 months on chemotherapy in second-line metastatic pancreatic cancer.
Trump to Nominate White House Aide Overton as FDA Commissioner
Dr. Heidi Overton, deputy director of domestic policy, has shaped the administration's vaccine schedule overhaul and drug pricing strategy from inside the White House.
Michigan Cyclospora Deaths Expose FDA Staffing Cuts as Vacancies Near One in Five
Two deaths confirmed Aug. 3 as FDA human food inspection vacancies approach 20 percent and CDC's parasite-tracking team falls from 11 scientists to three.
Warren Accuses Trump Administration of Quid Pro Quo in Cyclospora Outbreak
The Massachusetts senator's letter to RFK Jr. ties Taylor Farms' seven-figure donations to regulatory rollbacks she says raised the risk of the largest cyclosporiasis outbreak on record.
RFK Jr. Defends Agency Response as Cyclospora Outbreak Sickens Thousands
Health and Human Services Secretary Robert F. Kennedy Jr. faces scrutiny over federal budget cuts as a cyclospora outbreak sickens thousands across the country
Peptide Lobby Wins FDA Panel Vote Over Agency Scientists' Objections
The Pharmacy Compounding Advisory Committee voted 9-4 to add 20 peptide substances to the permitted compounding list, overriding internal FDA safety warnings.
Eli Lilly's Retatrutide FDA Bid Targets $25B Peak Sales in $100B Obesity Market
Lilly's triple-receptor weight-loss drug retatrutide heads to FDA with a 24 percent efficacy edge over rivals and a $1,200 price target from JPMorgan.
Supreme Court Weighs Mifepristone Access: Drugmakers Brace for Market Shift, Regulatory Fallout
The nation's highest court faces a critical decision on mail-order abortion pills, potentially reshaping the pharmaceutical market and igniting a new wave of political spending.